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FDA BLA · BLA761051

POTELIGEO

mogamulizumab-kpkc

Sponsor: KYOWA KIRIN

APPLICATION
BLA761051
TYPE
BLA
ORIGINAL APPROVAL
2018-08-08
LATEST ACTION
2026-02-19
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

POTELIGEOPrescription
MOGAMULIZUMAB-KPKC 20MG/5ML · INJECTABLE · INJECTION

Approval history

2026-02-19Labeling · Supplement 25 · standard — Letter ↗AP
2025-01-21Labeling · Supplement 18 · standard — Letter ↗AP
2022-03-30Labeling · Supplement 15 · standard — Letter ↗AP
2021-07-08Labeling · Supplement 11 · standard — Letter ↗AP
2018-08-08Type 1 - New Molecular Entity · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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